BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2992288 · Received March 7, 2013

    Report

    Report Number
    9614453-2013-00554
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED INSIGNIFICANT ANOMALIES. STIMULATION WAS FUNCTIONALLY OKAY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOT POSSIBLE TO PLUG THE LEAD INTO THE CHANNEL 1 (CONTACTS 0-7). IT WAS POSSIBLE TO PLUG THE SAME LEAD INTO THE CHANNEL 2 (CONTACTS 8-15). THE PLUG WAS OK AND IT WAS POSSIBLE TO PUSH IT UNTIL THE END. A NEW INS WAS USED AND THE PROBLEM WAS SOLVED. PATIENT STATUS AT THE TIME OF THIS REPORT WAS UNKNOWN. THE PATIENT WAS DESCRIBED TO BE OK. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98047 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1